PedaleoVR: Credibility, Usability and Intrinsic Motivation Study

NCT05162040 | Completed

• 1 other identifier: UsabilityPedaleoVR
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to combine the use of inertial systems with virtual reality in pedalling exercises in a pilot study with subjects with ataxia or hemiparesis. In particular, it is intended to evaluate the validity of the system as a physical training tool for pedalling exercises aimed at providing motivational visual stimuli and biofeedback based on pedalling cadence to improve the exercise experience and promote adherence to the subject's treatment. Primary objectives:

• To study the estimation of pedalling cadence performed by the system/platform in subjects with hemiparesis or ataxia..
• To study the usability, credibility and intrinsic motivation characteristics of the platform

Conditions

Ataxia, Motor; Hemiparesis

Outcome Measures

Primary Outcomes (3)

• Usability of the platform

  Outcome of the SUS questionnaire. The score ranges from 0 to 100. A score of 72.5 or higher is considered good and above 85.0 is excellent.

  through study completion, an average of 1 month.

• Credibility and Expectancy of the platform

  Outcome of the CEQ questionnaire. The score ranges from 0 to 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.

  through study completion, an average of 1 month.

• Intrinsic Motivation of the platform

  Outcome of the IMI questionnaire. The score ranges from 0 to 7. A score of 3.5 is considered neutral, everything above 3.5 is positive while everything under 3.5 is considered negative.

  through study completion, an average of 1 month.

Study Arms (1)

Experimental Group

Twenty participants joined the experimental group (15 males and 5 females, mean aged=61.10; SD=12.62) and provided written informed consent to be enrolled onto the study. Participants with neurological pathologies were diagnosed with (6) ischemic strokes, (1) hemorrhagic stroke, (1) thalamic stroke, (1) internal capsule stroke (3) traumatic brain injury (TBI), (1) Parkinson syndrome, (1) mixed axonal neuropathy with sensory demyelination, (1) progressive multifocal leukoencephalopathy, (1) secondary obstructive hydrocephalus, (1) angioma avernosus hemorrhage, (1) hemiprotuberancial hemorrhage - cavernoma, (1) ataxia and (1) cerebral artery aneurysm.

Device: Use of PedaleoVR

Interventions

Use of PedaleoVR DEVICE

All participants must undergo an evaluation of their motor skills through the application of physical assessment metrics performed by the physician. The metrics are the Timed Up-and-Go Test (TUG) and the 6-minute walk test. Next, they must perform a pedaling exercise on a bicycle or stationary pedaling station synchronizing the physical activity with the visual feedback from the virtual reality application. Two pedalling sets of 10 minutes each are performed, with 5 minutes of rest between sets. Finally, the participant is asked to rate the usability: System Usability Rating Scale (SUS), activity credibility (Credibility and Expectancy Questionnaire, CEQ) and intrinsic motivation (Intrinsic Motivation Inventory, IMI) of the virtual reality application.

Experimental Group

Eligibility Criteria

• Age: 39 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Twenty participants met these criteria (15 males and 5 females, mean aged=61.10, SD=12.62) diagnosed with (6) ischemic strokes, (1) hemorrhagic stroke, (1) thalamic stroke, (1) internal capsule stroke (3) traumatic brain injury (TBI), (1) Parkinson syndrome, (1) mixed axonal neuropathy with sensory demyelination, (1) progressive multifocal leukoencephalopathy, (1) secondary obstructive hydrocephalus, (1) angioma avernosus hemorrhage, (1) hemiprotuberancial hemorrhage - cavernoma, (1) ataxia and (1) cerebral artery aneurysm.

You may qualify if:

• Must had been prescribed pedalling exercise as treatment for lower limb rehabilitation caused by stroke, traumatic brain injury, neuro-motor disorders, and neuro-degenerative diseases.
• Must be able to perform a pedalling session with virtual reality technology.

You may not qualify if:

• An insufficient cognitive state, in particular, presence of dementia or mild cognitive impairment.
• An unbound bone fracture.
• Severe disorders of vision and/or audition (inability to perceive visual and/or auditory information coming from virtual reality)
• Those whose clinical record ruled out any incompatibility with the use of a virtual reality system.

Sponsors & Collaborators

• Werium Assistive Solutions: lead
• Centro Lescer: collaborator
• Cajal Institute of the Spanish National Research Council: collaborator

Study Sites (1)

Werium Assistive Solutions

Arganda, Madrid, 28500, Spain

Location

Related Publications (8)

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• J. Brooke. SUS - A quick and dirty usability scale. Usability Eval. Ind., 1996; 189 (194), pp. 4-7.

  BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Ryan RM. Control and information in the intrapersonal sphere: an extensión of cognitive evaluation theory. J Pers Soc Psychol. 1982; 43:450-61

  BACKGROUND

• Knippenberg E, Timmermans A, Palmaers S, Spooren A. Use of a technology-based system to motivate older adults in performing physical activity: a feasibility study. BMC Geriatr. 2021 Jan 28;21(1):81. doi: 10.1186/s12877-021-02021-3.

  PMID: 33509098 BACKGROUND

• Costa V, Ramirez O, Otero A, Munoz-Garcia D, Uribarri S, Raya R. Validity and reliability of inertial sensors for elbow and wrist range of motion assessment. PeerJ. 2020 Aug 11;8:e9687. doi: 10.7717/peerj.9687. eCollection 2020.

  PMID: 32864213 BACKGROUND

• Raya R, Garcia-Carmona R, Sanchez C, Urendes E, Ramirez O, Martin A, Otero A. An Inexpensive and Easy to Use Cervical Range of Motion Measurement Solution Using Inertial Sensors. Sensors (Basel). 2018 Aug 7;18(8):2582. doi: 10.3390/s18082582.

  PMID: 30087258 BACKGROUND

• Rojo A, Castrillo A, Lopez C, Perea L, Alnajjar F, Moreno JC, Raya R. PedaleoVR: Usability study of a virtual reality application for cycling exercise in patients with lower limb disorders and elderly people. PLoS One. 2023 Feb 22;18(2):e0280743. doi: 10.1371/journal.pone.0280743. eCollection 2023.

  PMID: 36812248 DERIVED

MeSH Terms

Conditions

Ataxia; Paresis

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Rojo, PhD Student

  Werium Assistive Solutions

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 17, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)